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Details for New Drug Application (NDA): 204618

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NDA 204618 describes ETOMIDATE, which is a drug marketed by Emcure Pharms Ltd, Hikma Farmaceutica, Zydus Pharms Usa Inc, Luitpold, Mylan Labs Ltd, Eurohlth Intl Sarl, and Par Sterile Products, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the ETOMIDATE profile page.

The generic ingredient in ETOMIDATE is etomidate. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the etomidate profile page.

Summary for NDA: 204618

Emcure Pharms Ltd
Formulation / Manufacturing:see details

Pharmacology for NDA: 204618

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 204618

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 204618 ANDA Heritage Pharmaceuticals Inc. 23155-160 23155-160-31 10 VIAL in 1 CARTON (23155-160-31) > 10 mL in 1 VIAL
INJECTABLE;INJECTION 204618 ANDA Heritage Pharmaceuticals Inc. 23155-160 23155-160-32 10 VIAL in 1 CARTON (23155-160-32) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Aug 13, 2014TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.